Multilayer Endografts are still an ongoing project but ... · Multilayer Endografts are still an...
Transcript of Multilayer Endografts are still an ongoing project but ... · Multilayer Endografts are still an...
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Multilayer Endografts are still an ongoing project but with a grounded scientific rationale
Prof. Domenico Palombo
Vascular and Endovascular Unit IRCCS San Martino – IST
University of Genova - Italy
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
introduction
• It’s a tubular, radiopaque, self-expandible bare stent.
• It consists of multilayer (3-5) braided wires made of a chrome and cobalt alloy
• Cobalt resistance to corrosion, compatible with MRI • The wires are curved at each point of intersection prevent
friction and preserve the shape • The two interconnected layers increase the anular resistance
and the radial elasticity • The best result is achieved at a 65% porosity
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
introduction
• Longitudinal flexibility and low profile • allows the penetration through tortuous/winding vessels • 20 Fr aortic • 8-12Fr peripheral
• Multilayer 3D structure • Tougher/more resistant • Prevent myointimal hyperplasia • Great expansion rate self fixing on arterial wall no migration
• Design • Consists in a radiopaque guiding catheter. • For peripheral use the delivery system can accommodate a 0,025 inch guide-wire • The stent can be removed or repositioned when <80% of its length has been extruded • Access preferentially from the femoral artery
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
introduction
key point is to change the flow
Turbulent Flow
Laminar Flow
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
• Turbulence increases, significantly, Local pressure and fluid shear stress in the aneurysm: this results in an enlargement and rupture of the vessel
introduction
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
introduction
• Turbulent Flows Are Naturally Laminated When the Volume of Porosity Reaches 50-65%
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
introduction
Advantages & Effects of The Lamination MFM®
1 2 3
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
1_Converting Turbulence to Lamination
• Multilayer Technology Converts Turbulence to Lamination
• With Three-Dimensional Porosity Range of 60-65%
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
Peak of Wall Shear Stress is an indicator of rupture -PWSS-
Weak Area (rupture)
1_Converting Turbulence to Lamination
Streamline: velocity field Surface: von Mises stress
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
3D Reconstruction
Applied Fluid _ Structure_ Interaction
Flow Velocity Pre & Post
High PWSS at the area of rupture
Reduction of Stress
1_Converting Turbulence to Lamination
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
Applied Fluid _ Structure_ Interaction
Flow Velocity Pre & Post
1_Converting Turbulence to Lamination
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
Vorticity Lamination
Without MFM With MFM
Applied Fluid _ Structure_ Interaction
Flow Velocity
1_Converting Turbulence to Lamination
pre
MFM
po
st M
FM
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
Applied Fluid _Structure _ Interaction –FSI- Flow Velocity Pre & Post
2_Branches Perfusion by Lamination
23% 24%
Flow Velocity Pattern PRE –MFM®-
Flow Velocity Pattern Post –MFM®-
25% Perfusion Improvement
pre
MFM
po
st M
FM
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
25% of Increased Blood Flow rate
Kidney Perfusion Improvement of 23 %
2_Branches Perfusion by Lamination
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
Lamination Effects MFM®
Integration
Endothelialization while keeping
branches perfused
3_Endothelialization while keeping branches perfused
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
Reinforcement of the wall
(3*) which regulates the
vascular tonus and strength
as a normal wall
Avoids any rupture
Explantation
36 months
(3 years)
Histolgy by NAMSA
Antoine Alves
Elastic lamina
lysis
First In Man (Dec 2006) - Dr M. Henry & Dr A. Polydorou, Athens
(Greece)
3_Endothelialization while keeping branches perfused
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
Clinical data
Converting Turbulence
to Lamination
Branches Perfusion by
Lamination
Endothelialization while keeping
branches perfused Lam
inar
Flo
w
No aneurysm
rupture risk
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
Clinical data
Unfortunately MFM is not for all patients
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
Clinical data
MFM different complications type Aortic arch rupture after multiple multilayer stent treatment of a thoracoabdominal aneurysm Ferrero E, Gibello L, Ferri M, Viazzo A, Nessi F. J Vasc Surg. 2013 Nov 4.
Aortic Arch Rupture
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
Clinical data
MFM different complications type
Severe visceral
ischemia
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
Clinical data
MFM different complications type
Aneurysm rupture
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
Clinical data
• Prospective
• Non randomized
• Multicenter
• Approved by the French Health Authority
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
Clinical data
30 day and 1 year follow-up:
No aneurysm-related mortality
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
Clinical data
Comparison with volume analisys: STRATO Trial 3 year follow-up (preliminary data) Courtesy C. Vaislic
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
Clinical data
Natural History of thoracoabdominal aneurysms
Elefteriades JA(1), Farkas EA. Thoracic aortic aneurysm clinically pertinent controversies and uncertainties. J Am Coll Cardiol. 2010 Mar 2;55(9):841-57
Italian experience and STRATO Trial No mortality related to TAAA and Juxtarenal aortic aneurysm rupture during follow-up
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
conclusion
Organized Laminar Thrombi of the aneurysm over time
Improves flow up to 20% into vital branches.
Endothelization of multilayered mesh occurs over time allowing the aneurysm to shrink.
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
conclusion
@Short and mid-term results seem to be encouraging even compared with the results of branched and fenestrated endograft
@Preoperative accurate planning and Follow-up is important as it is for the treatment with branched or fenestrated endograft
@Some patients cannot be treated with MFM because of unfavorable anatomy
@However, prospective studies are needed with larger series and longer follow-up
@Finally, coupling between experimental and clinical data
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
conclusion
University of Pavia
Vascular and Endovascular Surgery IRCCS San Martino IST - Genova
Team : Ferdinando Auricchio , Michele Conti, Elena Faggiano, Simone Morganti, Marco Fedele
Team : Domenico Palombo, Giovanni Spinella, Bianca Pane
University of Genova
Computational Mechanics &
Advanced Materials Group
Laboratory of Clinical and Experimental Vascular
Biology
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
conclusion
Experimental data Clinical data
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
conclusion
Specific analysis of patients CT scans:
Total volume, thrombus volume, flow volume
AIM 1)
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
conclusion
Hemodynamic analysis trough numerical simulations on
geometries patient-specific.
AIM 2)
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
conclusion
In vitro analysis (patients specific model) of MFM porosity trough
pressure value up-stream and down-stream and collateral vessels
AIM 3)
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Vascular and Endovascular IRCCS San Martino – IST University of Genova - Italy
Technology makes some surgeons better, some others only braver!
Prof. Domenico Palombo
Vascular and Endovascular Unit
IRCCS San Martino – IST
University of Genova - Italy